Kornimate/medical-research-clean huggingface dataset:
qigong for breast cancer survivors

Conditions: Neoplasms

Summary: objectives: (1) to investigate the effects of qigong training on upper limb oedema, circulatory status, shoulder flexibility and muscular strength, body balance, and quality of life (qol) in community-dwelling breast cancer survivors; and (2) to explore the relationship between the impairment outcomes and qol outcomes. hypothesis: (1) the experimental participants will have less impairment and a better qol after qigong training compared with the no-training control group; and (2) the impairment parameters will be related to the qol indexes in the qigong participants. design and subjects: this will be a prospective, randomised, single-blinded controlled trial. approximately 60 breast cancer survivors will be randomly assigned to either the qigong training group (n\~30) or control group (n\~30). intervention: participants in the qigong group will receive 18 forms of tai chi internal qigong training for 3 months with two supervised 1-hour sessions per week. main outcome measures: the primary outcome measures are upper limb circumference, arterial blood flow velocities and resistance index, shoulder joint passive range of motion, muscular strength (peak force) and body balance. the secondary outcome measure is quality of life as measured by the functional assessment of cancer therapy - breast scale. data analysis: data will be analysed via repeated-measures analysis of variance followed by post-hoc tests (α = 0.05). expected results: the investigators pilot studies produced encouraging results on the efficacy of qigong exercise in reducing chronic breast cancer-related symptoms in survivors. therefore, the investigators expect that participants in the qigong group will have fewer upper limb impairments and a better quality of life after qigong training. if the results are positive, this qigong training regime is readily transferrable to clinical practice, and could have positive socioeconomic effects such as reduced healthcare costs.


Eligibility criteria:
inclusion criteria: the inclusion criteria are 1. history of a breast malignancy of any stage 2. history of mastectomy or lumpectomy with or without adjuvant chemotherapy or radiotherapy 3. having completed conventional cancer treatment and medically stable 4. no known neurological deficits resulting from breast cancer treatment or other neurological disorders 5. persistent lymphoedema defined as a circumference difference greater than 2 cm at any point between the surgical upper limb and contralateral upper limb13 6. female aged 18 or above. exclusion criteria: the exclusion criteria are 1. presence of major psychiatric, neurological, musculoskeletal, cardiovascular, peripheral vascular or kidney disorder 2. receiving conventional cancer treatments such as chemotherapy or radiotherapy, medications such as diuretics or traditional chinese medicine 3. recurrent cancer or cancer that has spread to another organ 4. participation in regular physical activity 5. prior experience of qigong or tai chi 6. a smoking habit 7. pregnancy during the study period.
predictors for admission to emergency department more than 48 hours

Conditions: Length of Admission

Summary: in demark acutely admitted patients are supposed to stay in the emergency department (ed) bed ward if the anticipated duration of stay is less than 48 hours. however, it is not a trivial matter to estimate duration of stay for emergency patients. a number of factors affect this, eg. social background, disease, hospital organisation. the aim of this study is to analyse whom are the best among the health staff to predict the length of stay: ed nurses, admitting doctors og the specialist, and to analyse if a number of variables can be used to improve the prediction.


Eligibility criteria:
inclusion criteria: all patients admitted to the emergency department - exclusion criteria: children less than 15 years patients transferred from other hospitals -
the bipolar lithium imaging scan study.

Conditions: Bipolar Disorder I or II

Summary: the main goal of this study is to determine if brain lithium-concentrations predict clinical lithium treatment-response. secondary, to study correlations between intracerebral distribution-patterns of lithium with clinical treatment outcome. brain lithium concentrations will be measured using ultra-high field (7 tesla) lithium magnetic resonance (mr) imaging, which has recently been introduced. determining lithium-concentrations in the brain has been difficult so far due to lithium's relatively low concentration (compared to protons, which are targeted in conventional mri). 7t lithium mr imaging has the potential to produce much more detailed mr images compared with previous studies, for the first time. the bliss study is expected to yield new insights, helping to better understand why clinical lithium response varies between individuals.

introduction lithium treatment is considered the first-line pharmacological treatment for bipolar disorder. however, individual responses vary greatly, which undermines the ability to achieve rapid stabilization in many patients with bipolar disorder. the neurobiological mechanisms underlying lithium's action are still largely unknown, which hampers the development of clinically applicable predictors for individual treatment response. the recent introduction of ultra-high-field lithium magnetic resonance imaging offers a promising avenue to better link brain measures with clinical responses to lithium treatment. methods and analysis this is a longitudinal observational study involving 80 adults with bipolar disorder who are initiating lithium as part of their regular treatment regimen. ultra-high-field lithium magnetic resonance imaging of the brain will be performed within four weeks of reaching stable therapeutic serum lithium concentrations. the primary outcome is clinical response to lithium treatment at one-year follow-up, as measured using a validated questionnaire. linear regression analysis will be used to establish correlations between brain lithium concentrations-including whole brain, voxel-wise, parcellation, mean, and region-of-interest approaches-and clinical lithium response.

Eligibility criteria:
inclusion criteria: 1. age 18 years or above, 2. a clinical diagnosis of bipolar disorder type i or type ii , 3. having reached stable therapeutic serum lithium concentrations (reference values 0.6-1.0 mm in age to 65 years; 0.4-0.8 in age 65 years and above) within four weeks prior to study participation, and 4. provided written informed consent. exclusion criteria: 1. insufficient comprehension of the dutch language, 2. unable to provide informed consent, 3. drug or alcohol abuse over a period of two weeks prior to study participation, and 4. meeting any exclusion criterium for mr imaging.

Keywords: bipolar disorder lithium lithium mr imaging ultra-high field imaging clinical response clinical 7 tesla
study of high dose intravenous (iv) ascorbic acid in measurable solid tumor disease

Conditions: Sarcoma; Adenocarcinoma; Carcinoma; Multiple Myeloma; Desmoplastic Small Round Cell Tumor

Summary: the study is designed to determine if high doses of intravenous ascorbic acid (vitamin c) can be effective in managing solid tumor diseases. secondary goals are determination of any palliative effects and improvement of quality of life of patients.

ascorbic acid has demonstrated selective cytotoxicity in cancer cells in vitro, while sparing normal cells from its peroxidative effects. this study will examine the effect, if any, of the drug when dosed in patients at a level sufficient to achieve transient serum states of 400mg/dl. safety of the drug has been shown in a phase i study when dosed as high as 1.5gm/kg. patients will be treated twice weekly for 12 weeks (24-cycles) and evaluated for response using recist criteria. patients showing stable disease or objective response will remain on study for up to one year or until absence of measurable disease or disease progression.

Eligibility criteria:
inclusion criteria: * 18 years or older at time of entry on study * disease extent confirmed and documented by ct scan within 45 days of entry on study * normal glucose 6-phosphate dehydrogenase * no current calcium oxalate nephrolithiasis with the potential to reduce urinary flow * ability to understand the informed consent process and to give informed consent to treatment * measurable solid tumor neoplastic disease (using recist criteria) * life expectancy greater than 8-weeks * will agree to undergo central line placement (examples are: port-a-catheter, central venous catheter, percutaneously inserted central catheter \[picc\] line placement). patient or regular caregiver must be able to maintain flush central line as directed by study physician. (study center will provide periodic site dressing changes as required) * failed curative therapy or patient ineligible for definitive curative therapy * karnofsky performance status of at least 40 exclusion criteria: * any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, or ecg at baseline which, in the opinion of the investigator, may put the subject at risk because of his/her participation in the study * use of any nicotine product including nicotine patches/gum * unstable angina not well managed with medication * history of calcium oxalate stone formation * pregnancy or nursing of an infant * any psychiatric disorder by history or examination that would prevent completion of the study

Keywords: ascorbic acid vitamin c antioxidants vitamins
swallowing disorders in geriatrics studied with respiratory plethysmography by inductance

Conditions: Swallowing Disorders

Summary: the purpose of this study is to evaluate the efficiency of a novel non-invasive method for swallowing disorders detection in geriatrics.

interest: swallowing disorders exist at any age. more common among the elderly, their prevalence is estimated at between 15 and 50% of more than 60 years. recognized today as a health problem of particular concern within this population, their pathological consequences are multiple and severe: inhalation pneumonia, often a complication of "the wrong track", was recognized in the usa in 1989, as 5th cause of death among patients aged 65, and the 3rd leading cause of death of patients over 85 years. malnutrition facilitates infections by depression of the immune system and promotes the development of bedsores. the swallowing disorders resulting in an increase in the prevalence of dehydration, social isolation, but also an increase in mortality. faced with such consequences, it is therefore necessary to have a reliable, non-invasive approach adapted to the fragility of the elderly to detect these disorders in order to promote preventive strategies and / or curative justified. originality: this work, which is part of a clinical approach uses a new method of swallowing study, described in a. moreau-gaudry's medicine thesis : "assets of the respiratory inductance plethysmography to the study of swallowing in geriatrics." the originality of this lies in the combination of respiratory plethysmography by inductance (rpi) to the informatic tool. the pri allows continuous recording, thanks to a vest connected to a laptop, the patient's breathing rate. readily available at the patient's bedside, it is non-invasive and perfectly suited to the fragility of the study population. the tool, by its automatic guarantees objectivity and reproducibility of the analysis of deglutitions from respiratory signal provided by the rpi.

Eligibility criteria:
inclusion criteria: * patients major, consenting, cooperating. * person registered with the french social security or benefiting from an equivalent health insurance system exclusion criteria: * patients do not qualify for inclusion pre-cited, * patients in a period of exclusion for other studies, * patients with behavioural problems that prevent them joining a clinical trial requiring prolonged collaboration (state of rest with minimal mobilization of the patient, a necessary condition to acquire a breathing rate of quality, and therefore an analysis of quality), * patient suffering from a nosocomial infection, * patient the acute stage of a condition involving the life of the latter, * patient insufficient breathing, oxygen, with respiratory failure poorly supported despite oxygen, * patient in respiratory failure decompensated * patient at the end of life

Keywords: swallowing disorders geriatrics
trial of imatinib (gleevec®) in selected patients with metastatic melanoma

Conditions: Metastatic Melanoma

Summary: this study is a single-armed, open-label, single-center phase ii trial of signal transduction inhibitor number 571 (sti-571) systemic therapy in selective patients with metastatic melanoma, and aims to study the efficacy and safety. the primary endpoint is progression-free survival (pfs) and the second endpoints are overall response rate (orr), overall survival (os), 1-year os and safety.

only patients who meet the inclusion and exclusion criteria will be enrolled. the estimated recruitment duration is 1 year. imatinib will be given in the dose of 400 mg orally each day unless disease progression or intolerance. the follow-up is 12 months. forty-eight subjects will be recruited for this study. this sample size is justified by the number of patients required to establish an improvement in pfs with statistical significance compared to historical control. the standardized recist (response evaluation criteria in solid tumors) method of unidimensional tumor assessment will be employed to evaluate tumor lesion size per 2 months in the determination of response rate and progression free survival. repeated radiographic assessment at 4 week intervals is consistent with general oncological practice associated with computerized tomography (ct) or magnetic resonance imaging (mri) scan testing. all efficacy endpoints will be evaluated by the investigator. safety will be characterized in terms of the incidence, timing, severity, and relatedness of adverse events and laboratory abnormalities. severity will be graded according to the nci ctcae version 3.0.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed melanoma with metastases and has no received any systemic treatment within 1 month 2. evidence of mutations and/or copy number increases of kit with laboratory examination documented from either primary or metastatic tumor site 3. ecog performance status 0, 1, or 2 4. estimated life expectancy of 6 months or greater 5. age 18 years or older, male of female 6. at least one measurable site of disease 7. adequate organ function 8. willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures exclusion criteria: 1. melanoma from primary sites other than acral or mucosal melanoma 2. received systemic anti-cancer therapy within 1 month before enrollment for metastatic disease 3. diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer 4. severe and/or uncontrolled concomitant medical diseases 5. pregnant or childbreeding women 6. known hypersensitivity to imatinib 7. current treatment on another clinical trial

Keywords: metastatic acral or mucosal melanoma with c-kit mutation or copy number increase
oligomeric alpha-synuclein in multiple system atrophy

Conditions: Multiple System Atrophy (MSA)

Summary: the main objectives are to determine on one hand whether oligomeric alpha-synuclein levels are increased in msa patients compared to controls and on other hand whether there is a good agreement between cerebrospinal fluid (csf) and plasma levels.

multiple system atrophy (msa) is a rare neurodegenerative disorder which is characterized by a variable combination of parkinsonism, cerebellar dysfunction, autonomic failure, and additional signs. no effective treatment is available. together with pd and lewy body dementia, msa belongs to a group of neurodegenerative disorders, the alpha-synucleinopathies, which are characterized by the abnormal accumulation of alpha-synuclein. the development of biological markers for the diagnosis and prognosis in msa remains an unmet need. such biological markers are crucial for future disease-modification and neuroprotection trials. alpha-synuclein has a high potential for biomarker development since it constitutes the pathological hallmark feature in msa. the oligomeric alpha-synuclein seems to be particularly involved in abnormal protein aggregation in alpha-synucleinopathies. the study will compare alpha-synuclein levels in csf and plasma between patients suffering from ams and controls who are patients requiring spinal tap without being affected by a neurodegenerative disorder. the msa patients and controls will receive csf and blood sampling at one study visit.

Eligibility criteria:
* msa patients o inclusion criteria: patients suffering from "probable" msa according to clinical consensus criteria (gilman et al, 2008), age \>30 written informed consent patient covered by the national health system o exclusion criteria: umsars iv score \> 4 points patient under tutelage patient unable to give consent patients receiving anticoagulants, showing abnormal coagulation on blood testing or thrombocytopenia are excluded from this study * controls (patients requiring spinal tap without suffering from a neurodegenerative disorder) o inclusion criteria: patients not suffering from a neurodegenerative disorder and requiring a spinal tap age \>30 written informed consent patient covered by the national health system o exclusion criteria: similar to msa patients

Keywords: multiple system atrophy (msa) alpha-synucleinopathies biological markers cerebrospinal fluid plasma
risk of hepatitis b reactivation after bone marrow transplantation with prior hepatitis b virus (hbv) exposure

Conditions: Exposure to Hepatitis B Virus

Summary: the purpose of this study is to determine whether preemptive nucleoside analogue therapy or regular virologic monitoring is the preferred method in management patients with prior exposure to hepatitis b vius (hbv) and undergoing hematopoietic stem cell transplantation (hsct).

occult hepatitis b virus (hbv) reactivation has been documented in bone marrow transplantation recipients who are hepatitis b surface antigen (hbsag)-negative but with serologic evidence of prior exposure to hbv. however detailed prospective studies documenting the incidence of reactivation and the virologic and serologic kinetics of reactivation are lacking. the investigators prospective study proposes to follow-up 50 such bone marrow transplant recipients with all serologic and virologic parameters monitored every 4 weeks. patients with detectable hbv dna will be started on nucleoside analogue therapy. the optimal method and duration of monitoring will also be determined from our study.

Eligibility criteria:
inclusion criteria: * documented hbsag-negative hsct recipient with or without antibody to the hepatitis b surface antigen (anti-hbs). * documented anti-hbc (total)-positive. exclusion criteria: * concomitant liver diseases including chronic hepatitis c and d infection, wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis. * significant alcohol intake (\>30 grams per day)

Keywords: hepatitis b anti-hbc hbsag hsct recipients
a phase 1/2, open-label, dose-escalation, safety study of incagn01949 in subjects with advanced or metastatic solid tumors

Conditions: Advanced Malignancies; Metastatic Cancer

Summary: the purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of incagn01949 in subjects with advanced or metastatic solid tumors.


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. * subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. there is no limit to the number of prior treatment regimens. * part 1: subjects with advanced or metastatic solid tumors. * part 2: subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer. * presence of measureable disease based on recist v1.1. * eastern cooperative oncology group performance status 0 or 1. exclusion criteria: * laboratory and medical history parameters not within the protocol-defined range. * receipt of anticancer medications or investigational drugs within the protocol-defined intervals before the first administration of study drug. * has not recovered to ≤ grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy. * receipt of a live vaccine within 30 days of planned start of study drug. * active autoimmune disease that required systemic treatment in the past.

Keywords: solid tumor adenocarcinoma of the endometrium ovarian cancer renal cell carcinoma melanoma non-small cell lung cancer ox40 immunoglobulin g monoclonal antibody
systemic inflammatory response syndrome (sirs) in patients undergoing major procedures in oral and maxillofacial surgery

Conditions: Systemic Inflammatory Response Syndrome (SIRS)

Summary: patients undergoing major procedures in oral and maxillofacial surgery more often develop a systemic inflammatory response syndrome (sirs) in the first days of postoperative critical care therapy than patients with a comparable major surgery in other regions. the reasons for this finding are unknown and have not been studied in depth so far. we hypothesize that surgical trauma in this region might activate pro-inflammatory pathways. by examining the proteome of patients at different stages (prior to the surgery, at icu admission, on the second postoperative day and when sirs has ended clinically), we aim to identify the involved pro-inflammatory pathways and identify possible target proteins that might be clues to modification of postoperative sirs in the future.


Eligibility criteria:
inclusion criteria: * age 18-99yrs * scheduled for elective surgery with risk for development of sirs * written and informed consent exclusion criteria: * age \<18yrs * pregnancy * emergency surgery * failure to obtain patient consent